Neonates With Very Low Birth Weight and Surgery Therapy of Acute Abdomen

Overview

Objective: Due to high mortality rates the capillary leakage and the acute abdomen are important risk factors of the probability of survival. The aim of an optimal therapy of the acute abdomen within the neonatal period is beside the cure of the underlying disease the prophylaxis of capillary leakage with the help of optimised intra- and postoperative volume therapy. Question: Do the neonates with very low birth weight and a surgery therapy of acute abdomen benefit from early increase of the haemoglobin/haematocrit by optimised volume therapy with crystalloid and colloidal volume as prophylaxis of the capillary leakage?

Full Title of Study: “Retrospective Analysis of Intraoperative Volume Administration in Neonates Without Congenital Malformations With Very Low Birth Weight and Acute Abdomen.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 2011

Arms, Groups and Cohorts

  • Neonates
    • Neonates with very low birth weight and surgery therapy of acute abdomen

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative Capillary Leakage
    • Time Frame: 48 hours from Baseline (Operation)
    • Postoperative Capillary Leakage (defined as weight gain within 48 hours or development of oedema within 48 hours)

Secondary Measures

  • Amount of transfusions during surgery
    • Time Frame: Up to 5 hours
  • Re-surgery rate
    • Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
  • Length of stay
    • Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
  • Mortality
    • Time Frame: Up to 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • All Children with very low birth weight who have undergone surgery of acute abdomen within the neonatal period between 2001 and 2011 on "Campus Charité Mitte" or "Charité Virchow – Klinikum". – Neonates (calculated date of birth + 4 weeks) Exclusion criteria:

  • Birth weight > 1500g

Gender Eligibility: All

Minimum Age: 1 Minute

Maximum Age: 4 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Charite University, Berlin, Germany
  • Provider of Information About this Clinical Study
    • Principal Investigator: Claudia Spies, Department of Anesthesiology and Intensive Care Medicine, CVK and CCM – Charite University, Berlin, Germany

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